Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Ivenix Infusion System (IIS) Recalled by Fresenius Kabi USA, LLC Due to Software version 5.10.1 and earlier contain anomalies that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Kabi USA, LLC directly.
Affected Products
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Quantity: 30 units
Why Was This Recalled?
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Where Was This Sold?
This product was distributed to 20 states: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NV, NJ, OK, OR, SC, TX, VA, WA, WI
About Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report